Decision Systems for Quality & Regulatory

Your quality system documents
what happened.
ParanoiaIQ decides what to do next.

AI decision engines for CAPA, complaint investigation, field action, and risk — structured, defensible, and built to survive FDA scrutiny.

Every output produced by AI. Every decision approved by you. No event gets misclassified.

See what the output looks like → Contact Us
65% cycle time reduction
0.4% repeat rate
Zero audit findings across 32 audits
MDIC pilot · 8 manufacturers
65%
of Class I recalls are
design failures — risk built in from the start
Mooghali M et al., Medical Devices: Evidence and Research, 2023. PMID 37229515. n=189 Class I recalls, 2018–2022.
30mo
median time from distribution
to recall — the signal existed long before the action
Ibid.
66%
of recalled devices had
a prior recall — the same decision failures repeat
Ibid.
See It In Action

This is what a quality event looks like
when it's handled correctly.

Two real tool runs. Full regulatory output. No signup, no sales call — open them now.

CAPA Investigation
CRITICAL
Life-sustaining device · flow rate over-delivery · 23 units at final QC
FlowMaster IV infusion pump. 14.8% over-delivery. Full opening analysis: problem statement, scope boundary, containment plan, field action risk, deadlines, investigation agenda.
CRITICAL Tier Field Action: HIGH Root Cause Due 30 days IS / IS NOT Defined 7-step Agenda
View CAPA Sample Output →
Complaint Investigation
MDR REPORTABLE
Spinal implant structural failure · revision surgery · 8.5 years post-op
TitanSpine lumbar fusion system. Cage fracture during explant. Full investigation: MDR determination, 30-day deadline, risk score, trending signal, CAPA trigger, investigation plan.
MDR Reportable 30-day Deadline Trending Signal Risk: 16 / HIGH 7-tool Analysis
View Complaint Sample Output →

Ready to run your own event? Use the live tools: CAPA Investigation · Complaint Investigation

Case Study

One complaint. Two engines.
One documented decision.

Based on a real Class I recall · Angiographic rotating adaptor syringe · March 2026 · Four serious injuries before recall initiation
Step 1 — Event Intake
Field complaint logged
Rotating adaptor loosening under torsional load during cardiac catheterization. Field rate exceeds documented FMEA parameters. CAPA Gate evaluation begins.
Step 2 — CAPA Gate
Frequency trigger fires
Severity: not triggered. Management: not triggered. Frequency: complaint rate exceeds FMEA threshold across distributed units. CAPA opened.
CAPA Opened
Step 3 — CAPA Engine
Problem in Focus defined
Scoped precisely: rotating adaptor connection loosening under torsional load during high-pressure injection in cardiac catheterization, at a field complaint rate exceeding FMEA probability threshold. Not "syringe failure." Not "loose adaptor."
Step 4 — HHE Engine
Risk Level: High · Class I
Probability: Occasional. Severity: Catastrophic. Probability Override Rule applies. Class I determination made. Field Action Engine activated.
Class I · Field Action
Step 5 — Field Action Engine
Urgent voluntary recall
Life-sustaining device confirmed. Market withdrawal insufficient. Scope: all affected lot numbers. Recommendation: Urgent voluntary recall. 21 CFR Part 806 filing triggered.
Recall Initiated
Step 6 — Human Gate
Decision documented
Quality professional reviews full packet in one session. Decision documented, timestamped, audit-ready before next morning. AI structured. Human approved.
Audit-Ready
"Opening the CAPA was correct. The failure was in how risk was evaluated and acted on inside it. When effectiveness failed and complaint rates exceeded thresholds, the system did not escalate. It closed the CAPA and opened another. That is the gap: not detection, but failure to act on signal." — Matt Collins, ParanoiaIQ™
FDA Warning Letter 723866 · Medline Industries LP · March 25, 2026 · 21 CFR 820.100
Engagements

Four engagements. Every regulatory situation.

Start with the diagnostic. No budget approval risk. Immediate deliverable. If you have an inspection in 90 days, start today.

Start Here
Level 1
IQx Diagnostic
From $20K · 1 week
Assessment against 21 CFR 820.100, ISO 13485, and CP 7382.850. Gap report across CAPA, QMS, risk file, and regulatory posture. Recommends the right next engagement.
  • Structured gap report with priority ranking
  • Findings readout with regulatory framing
  • Recommended path forward — no obligation
Start with Diagnostic
Level 2
Problem in Focus Sprint
From $40K · 2–4 weeks
Faster CAPA closure. Repeat rate reduction. Scope control from day one. The decision logic becomes part of your team's SOP — not just a deliverable.
  • Routing framework in SOP
  • Effectiveness check playbook (Types 1–4)
  • Backlog triage included
  • Optional: AI CAPA Engine in eQMS
Get Started
Level 4 — Emergency
FDA Response Sprint
From $75K · 2–3 weeks
483 observation response. Warning Letter CAPA plan. AI Notice response. Every commitment tied to real corrective action. Built on Problem in Focus framework.
  • 483 response — defensible, deadline-driven
  • Warning Letter remediation architecture
  • Human oversight documentation for AI tools
Contact Us
Level 3
Ongoing Retainer
From $10K/mo · 6-month minimum
All five engines. Continuous access. Management review support. Inspection prep. CAPA and field action advisory. Priority response within 4 hours.
  • Unlimited advisory on active events
  • Inspection readiness — ongoing
  • Management review support
Discuss Retainer
A single FDA Warning Letter costs $500K–$2M+ in remediation, lost production, and consultant fees. The Problem in Focus Sprint costs $40–75K and leaves your team with the skill, the SOP, and the precision to prevent the next one.
Get in Touch →
Free Tools

Built from the same methodology. Free.

No sales call required. These are the actual frameworks, not marketing content.

Checklist · PDF
CAPA Problem Definition Scorecard
12-point scoring tool for problem statements before RCA begins. If your CAPA can't pass this, it will fail FDA scrutiny.
Decision Guide · PDF
Is This a Recall? Field Action Decision Guide
Step-by-step decision tree covering 21 CFR Part 806, recall vs. withdrawal vs. no action, and when to call FDA first.
Analysis · Article
FDA's AI Warning Letter: What It Means for Your QMS
FDA's first Warning Letter citing AI overreliance — April 2026. What "human review" means under 21 CFR 211.22(c) and how to comply by design.
Read Now →
Get Started

The recall you prevent is the one nobody hears about.

Walk your last quality event through the engine. We'll show you exactly where the decision would have changed. 20 minutes. No integration required.

📧 mcollins@paranoiaiq.com · Response within 24 hours
🔗 LinkedIn — Matt Collins
Matt Collins — 25 years inside quality and regulatory decisions at Abbott, Fresenius, Integra, NuVasive, and Exactech. Warning Letter remediation, consent decree compliance, Class I recall management, FDA inspection readiness. ParanoiaIQ™ is the system built from those decisions — not a consulting slide deck.

65% cycle time reduction · 0.4% repeat rate · Zero audit findings across 32 audits — MDIC pilot, 8 manufacturers.

Start the Conversation

Or email directly: mcollins@paranoiaiq.com
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